FDA asks makers of vaginal mesh to respond to safety queries

By Dr. Ananya Mandal, MDJan 5 2012

The U.S. Food and Drug Administration (FDA) has ordered Johnson & Johnson and C.R. Bard Inc. to study rates of organ damage, infection and painful sex linked to vaginal mesh implants, in response to doctors and patients who say the devices have harmed women.

The FDA wrote J&J, C.R. Bard and 31 other manufacturers this week, asking them to collect as much as three years of data on the safety and effectiveness of the implants, the agency's William Maisel said. That followed an FDA report in July that found a fivefold jump in deaths, injuries or malfunctions linked to some of the products. The requests went to companies including Endo Pharmaceuticals Holding Inc. (ENDP) of Chadds Ford, Pennsylvania, and Boston Scientific Corp. (BSX), based in Natick, Massachusetts. The companies have 30 days to respond.

The meshes were approved through the FDA's 510(k) system, which allows products to reach the market without human testing if the agency decides they're similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific mesh recalled for safety problems in 1999.

Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices' alleged failures have spurred more than 650 lawsuits against manufacturers, as well as heightened scrutiny of the FDA program that cleared meshes for sale without human testing. Maisel, deputy director of science for the FDA's device-approval center said, “We believe there are certain uses of mesh where we need additional data to help guide the clinical community… Our goal is to make sure the right women use it at the right time.”

The edges of mesh fibers can constrict or cut into internal organs after they've been implanted, studies have found. The procedure is also prone to infection because the vagina through which the devices are inserted isn't a sterile environment, said Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University School of Medicine, said.

Matthew Johnson, a spokesman for J&J's Ethicon unit that makes the devices, said the company was reviewing the correspondence from the FDA. “Ethicon's transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials,” he said.

In September, an advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs, as “high-risk” devices that require human testing. The FDA hasn't made a decision yet, Maisel said today. He said the agency also isn't likely to heed the call of some patient advocates for a complete recall. “There's strong support in the clinical community that mesh serves a role for certain patients,” he said. “Our goal is not to completely remove these products from the market.”

Manufacturers sell about $175 million worth of prolapse mesh worldwide. Currently J&J is the biggest maker of vaginal mesh and it fell less than 1 percent to $65.48 at the close in New York. C.R. Bard also declined less than 1 percent to $86.08. J&J is based in New Brunswick, New Jersey, and Bard in Murray Hill, New Jersey.